Dietetic Products Research Articles

In vitro fermentation assay on the bifidogenic effect of steviol glycosides of Stevia rebaudiana plant for the development of dietetic novel products

The relationship between excessive sugar consumption and many diseases such as dental caries, obesity, diabetes and coronary heart has been increasing in recent years. In this study, utilization of natural sugar replacer steviol glycosides and bifidogenic effect by Bifidobacterium animalis subsp. lactis was assayed in vitro model system. The basal medium (non-carbohydrate containing MRS, Man, Rogosa and Sharpe Agar) were supplemented with 0.025% and 1% stevia, 0.025% stevia + 1% inulin, %1 stevia + 1% inulin. The medium which contained no carbohydrate was designated as negative control, whereas the medium containing 1% glucose or inulin were evaluated as positive and evaluated on the 0, 12, 24, 36 and 48 h of fermentation. Steviol glycosides in both system significantly stimulated the growth of Bifidobacterium animalis subsp. lactis to varying degrees with highest prebiotic activity score, short chain fatty acid production and growth parameters as much as glucose and prebiotic inulin. The viability of the probiotic bacteria was determined within the bio-therapeutic level with potential prebiotic effects depending on the probiotic bacterial strain growing and the type of carbohydrate source utilized. In the study, stevia at lower concentration showed a higher growth rate of with inulin. In conclusion, stevia can be used as functional ingredients for the modulation of the gut microbiota and design of synbiotic systems as a prebiotic substrate and sugar substitute.

Yava (Barley): A Potential Dietary Component for Management of Metabolic Disorders W.S.R. To Diabetes Mellitus-A Multi Case Report

Yava or Barley (Hordeum vulgare L.) of Triticaceae is one of the most celebrated cereals of Ayurveda. Yava is a nityasevaneeya dravya meaning, that which can be consumed on a regular basis and is conducive to health. Classically, Yava has been mentioned as a potent dietary component in many conditions which can now be placed under the umbrella term of metabolic disorders. Understanding the holistic potential of yava in addressing the pathogenesis of prameha is a key to develop newer dietary supplements out of it. This article explores the utility of Yava as a dietetic product in metabolic disorders with special reference to Diabetes mellitus. Yava was included in the daily diet of Diabetic patients for a period of 1 month and their blood glucose levels were assessed. It was noted that there was significant improvement in the glycemic control in selected patients of Diabetes mellitus.

Dietetic Food Products Based on Pumpkin Flour (Curcuma Moschata)

The general objective of this research is to develop food diversification based on pumpkin flour to increase food security. Pumpkin contains an active component ie - carotene which has potential as a raw material for making diet food formulas for infants, elderly and people with degenerative diseases. The formula used in the development of diet foods is based on applicable standard methods (Ministry of Health and FAO). Elderly food products were made from pumpkin flour, soybean flour, skim milk, and sucralose sugar in the form of porridge. The best instant pumpkin porridge formula has the characteristics of bulk density 0.6235 g/mL, rehydration time 57 seconds, contains 4.98% water, 5.81% ash, 5.90% fat, 10.77 % protein, 8.10% crude fiber, 62.44% carbohydrates, and 3673.06 g/g-carotene. Dietetic products for diabetics were pumkin noodles with addition of glucomannan as a binder and palm sago starch. The selected pumkin noodle product was made from treatment of pumpkin flour and palm sago starch with a ratio of 30:70. The selected treatment pumkin noodles had physical characteristics, namely the value of hardness 530.25 gf, adhesiveness 0.62 gf and elasticity 0.76 mm. This product contains 57.75% water, 1.44% ash, 6.87% protein, 392.15 g/g-carotene and 563.214 ppm antioxidant activity.

Assessment of the nutritional adequacy of dietetic food products available in Portuguese supermarkets

Assessment of the nutritional adequacy of dietetic food products available in Portuguese supermarkets

Acceptability of yacon flakes (Smallanthus sonchifolia) for dietary use with inulin

This study aimed to elaborate on yacon flakes and determine the proximal composition of fresh yacon and final flakes, made at different temperatures (120°C, 150°C and 180°C) for 20 mins. We measured the acceptability of the sensory attributes: taste, texture, odour and colour and the global acceptability at the laboratory level, using semi-trained panellists and an unstructured hedonic scale. The acceptability of the flakes was measured at different temperatures. Our results indicate that the flakes made at 180°C had the highest acceptance (87%), and the flakes made at 120°C had 80% of unacceptability. Our data were analysed according to the analysis of variance (ANOVA) and Tukey's test. We found significant differences between the averages of the taste scores (T0:7.1; T1:7.6; T2:6.7; T3:4.6), p<0.05; texture (T0:7.1; T1:7.2; T2:5.7; T3:4.5), p<0.05; and odour (T0:7.2; T1:7.6; T2:5.1; T3:3.3), p<0.05. The amount of fructooligosaccharides on a fresh basis was Ⱦ±SD (31.60±0.650) and on a dry basis (37.44±1DS). Microbiological analysis shows that the flakes are fit for human consumption. It is concluded that yacon flakes contain significant amounts of inulin, being a good substitute alternative for the preparation of snack-type dietetic products.

Gıda ve Yem için Hızlı Alarm Sistemi’nde yer alan çevresel kirletici bildirimleri

Rapid Alarm System for Food and Feed (RASFF); is a database created by the European Commission that provides rapid information flow and response when risks to public health are identified in the food chain. Within the scope of this study, a detailed report was prepared on the notifications of environmental pollutants in foods in the Rapid Alarm System database between 2000 and 2020. All data obtained from the system were evaluated using Microsoft Office Excel 2010. When 774 notifications made in 21 years were examined, it was determined that 32% of the notifications were about “fish and fish products”, 29% about “oils and fats” and 11% about “dietetic products and food supplements”. The main problem (12% of the notifications) was determined to be “polycyclic aromatic hydrocarbons”. Among all notifications, 33% of them were found to have a “serious risk” degree. The highest number of notifications (81 notifications) was detected in 2001. Additionally, 61% of the notifications were in the “alert”, 13% “information”, 11% “information for attention”, 11% “border rejection” and 4% “information follow-up” notifications. Most of the notifications (415 notifications) were created as a result of official controls in the market. Germany was the country with the highest notifications, with 178 notifications. As a result of the notifications, sanctions were generally imposed on “withdrawal of products from the market” and “withdrawal of products from the market by the manufacturer”. Considering the decrease in PAH notifications from food-related environmental pollutants over the years, it can be thought that the Rapid Alert System was effective in the decrease in the number of notifications.

Risk Assessment on Use of Lactobacillus rhamnosus (LGG) as an Ingredient in Infant Formula and Baby Foods (II)

On 10. March 2006 , The Norwegian Food Safety Authority (Mattilsynet) decided that, on the basis of VKM’s previous risk assessment (2005), Nutramigen 1 with Lactobacillus rhamnosus GG (LGG) could not be marketed in Norway as medical foods for infants (0-4 months). In addition, The Norwegian Food Safety Authority (Mattilsynet) decided (08. November 2006) to withdraw permission for marketing of Nutramigen 2 with LGG, which is a milk supplement for infants aged between 4 and 6 months, with cow’s milk and soy protein allergy. On 13. December 2006, Mead Johnson Nutritionals appealed against this decision from The Norwegian Food Safety Authority (Mattilsynet). The Norwegian Food Safety Authority forwarded the appeal from the companies, asked the VKM Panel on biological hazards and the VKM Panel on nutrition, dietetic products, novel food and allergy, for a new risk assessment including the new data provided in the appeal.
 LGG is one of the most studied probiotic strains. Lactic acid produced by LGG in the human gut results in a decrease in faecal pH, which in turn inhibits colonisation by potentially pathogenic bacteria. Short-term beneficial effects from administration of LGG to infants and young children with infectious diarrhoea have been reported in a number of studies, but a prophylactic effect on diarrhoea has not been documented. Furthermore, whilst some studies have reported a prophylactic, or even a curative, effect of LGG on atopic eczema in young children, more recent studies do not report such effects. Some even suggest an increased incidence of allergic sensitization in children receiving LGG supplemented formula at an early age. There are no published data that demonstrate long-term clinical benefits of infant formula supplemented with LGG for children between 4 months and 3 years, although no immediate deleterious effects of LGG have been found. Possible long-term effects of LGG on intestinal colonisation, and its effects on long-term gastrointestinal and immune functions, are not known.
 LGG, as an ingredient in infant formula and baby foods, is intended for daily use in the target group, and not for short-term, specific treatment. Furthermore, the targeted consumer group includes children below the age of twelve months. These two aspects demand particular consideration with regard to the unknown effects of long-term treatment with large doses of live bacteria on the ecology of the microbiota of the gastrointestinal tract and on the immune system. Neither of these systems is fully matured in infants and small children, and therefore may be particularly susceptible.
 There is no documented prophylactic effect of LGG on any disease in children. The effect of treatment with LGG-supplemented formula in small children is questionable, except for a documented short-term effect on infectious diarrhoea. Panel on Biological Hazards and Panel on nutrition, dietetic products, novel food and allergy at the Norwegian Scientific Committee for Food Safety find that the data available are not sufficient to support the suggested beneficial effects, or the safety, of LGG in infant formula and baby foods for children aged between 4 months and 3 years, when the products are intended for daily use.

Assessment of Very Low Calorie Diets

Very low calorie diets (VLCD products) are formulated products with 450 – 800 kcal per day intended to replace the whole diet. Regulation of VLCD is not harmonised in the EU, and there is no specific national Norwegian legislation for these products. The Norwegian Food Safety Authority has requested VKM to propose minimum and maximum limits for the content of fat/ fatty acids, protein, carbohydrates, vitamins and minerals in VLCD products based on acknowledged scientific documentation. VKM is also asked to evaluate if VLCD products are suitable in the treatment of obese subjects with type 2 diabetes, and possible contraindications for use of VLCD.
 This assessment is based upon the SCOOP-report “Collection of data on products intended for use in very-low-calorie-diets” (SCOOP, 2002) and new literature mainly after 2002. 
 Based on the available scientific literature, the VKM Panel on nutrition, dietetic products novel food and allergy has concluded that, on a daily basis, VLCD products should provide minimum 55 g carbohydrates, 10 g fibres, 50 g high quality protein and 7 g fat, including 3 g from linoleic acid and 0.5 g from α-linolenic acid. The amino acid scoring pattern should be in accordance with the protein-digestibility-corrected amino acid score. 
 VLCD products should provide minimum 10 µg vitamin D per day, and the minimum recommended daily intake for the other vitamins and minerals.
 No maximum limits are suggested for carbohydrates, protein or fat, as the energy will be the limiting factor. The fibre content should not exceed 30 g per day, and the VKM Panel recommends that the maximum limits for vitamins, minerals and trace elements should equal two times the recommended daily intake.
 VLCD will give short-term weight loss and improvement in blood pressure, serum lipids and glycemia in obese subjects with type 2 diabetes, and no serious adverse effects have been reported. VLCD may impede the educational process needed in the treatment of diabetes, and should therefore only be used as part of an educational program in obese subjects with type 2 diabetes, and only under medical supervision. 
 VLCD is contraindicated in children, adolescents, pregnant and lactating women, elderly (above 65 years old) and in subjects with heart failure, cerebrovascular disease, gallstone disease, kidney- and liver diseases, psychiatric disorders, and in subjects with BMI ≤ 30 kg/m2. In addition one should be aware of the reducing effect of VLCD on blood pressure and the effect on hyperglycaemia which may cause problems if pharmacological therapies for these conditions are given. Medical supervision is recommended if VLCD treatment exceeds 3 weeks.
 To prepare this report, VKM established an ad hoc group (members listed above). The VKM Panel on Nutrition, Dietetic Products, Novel Food and Allergy has discussed and adopted this opinion.

Assessment of Infant Formulae Based on Partially Hydrolysed Proteins

The regulation of infant formulas is under revision, including the national restriction on sales of infant formulas with partially hydrolysed proteins to pharmacies only. In December 2007 the Norwegian Food Safety Authority requested an opinion from the Norwegian Scientific Committee for Food Safety on infant formulas with partially hydrolysed protein. The opinion should cover an evaluation of risks associated with the replacement of conventional infant formulae (based on intact protein) by infant formula based on partially hydrolysed protein, including a specification of the risks associated with the consumption of infant formula based on partially hydrolysed proteins among infants with cow’s milk allergy. Furthermore, the opinion should include an evaluation of the preventive effect from formula with partially hydrolysed proteins on development of cow’s milk allergy.
 To complete this task, VKM has established an ad hoc group that has prepared this report. The Panel on Nutrition, Dietetic Products, Novel Food and Allergy has discussed and adopted this opinion.
 The main conclusions are that although no studies show that partially hydrolysed formulas have negative effect on growth, measures should be taken in order to avoid that partially hydrolysed formulas replace regular infant formulas in the general population. Hydrolysed proteins have a high absorption rate, and ingestion of hydrolysed proteins have been shown to increase gastric emptying and plasma glucose-dependent insulinotropic polypeptide relative to the intact protein forms.
 Feeding partially hydrolysed formulas to infants with cow’s milk allergy constitutes a risk of eliciting an allergic reaction which in worst case may be fatal. The risk that an infant with cow’s milk allergy will receive partially hydrolysed formula may increase if the products are sold with claims such as reduced risk towards cow’s milk allergy and reduced risk of developing cow’s milk allergy together with ordinary infant formula outsides pharmacies.
 The risk of developing cow’s milk allergy is not shown to be reduced by introducing partially hydrolysed formula instead of regular formula during the first 4-6 months. There has not been demonstrated any preventive effect from hydrolysed formulas after the age of 6 months on the development of allergic disease.

Safety Assessment of Vitamin D and Its Photo-Isomers in UV-Irradiated Baker's Yeast.

Vitamin D deficiency due to, e.g., nutritional and life style reasons is a health concern that is gaining increasing attention over the last two decades. Vitamin D3, the most common isoform of vitamin D, is only available in food derived from animal sources. However, mushrooms and yeast are rich in ergosterol. This compound can be converted into vitamin D2 by UV-light, and therefore act as a precursor for vitamin D. Vitamin D2 from UV-irradiated mushrooms has become an alternative source of vitamin D, especially for persons pursuing a vegan diet. UV-irradiated baker’s yeast (Saccharomyces cerevisiae) for the production of fortified yeast-leavened bread and baked goods was approved as a Novel Food Ingredient in the European Union, according to Regulation (EC) No. 258/97. The Scientific Opinion provided by the European Food Safety Authority Panel on Dietetic Products, Nutrition, and Allergies has assessed this Novel Food Ingredient as safe under the intended nutritional use. However, recent findings on the formation of side products during UV-irradiation, e.g., the photoproducts tachysterol and lumisterol which are compounds with no adequate risk assessment performed, have only been marginally considered for this EFSA opinion. Furthermore, proceedings in analytics can provide additional insights, which might open up new perspectives, also regarding the bioavailability and potential health benefits of vitamin D-fortified mushrooms and yeast. Therefore, this review is intended to give an overview on the current status of UV irradiation in mushrooms and yeast in general and provide a detailed assessment on the potential health effects of UV-irradiated baker’s yeast.

Targeting the Tumor Extracellular Matrix by the Natural Molecule 4-Methylumbelliferone: A Complementary and Alternative Cancer Therapeutic Strategy.

In antineoplastic therapy, one of the challenges is to adjust the treatment to the needs of each patient and reduce the toxicity caused by conventional antitumor strategies. It has been demonstrated that natural products with antitumoral properties are less toxic than chemotherapy and radiotherapy. Also, using already developed drugs allows developing substantially less costly methods for the discovery of new treatments than traditional drug development. Candidate molecules proposed for drug repositioning include 4-methylumbelliferone (4-MU), an orally available dietetic product, derivative of coumarin and mainly found in the plant family Umbelliferae or Apiaceae. 4-MU specifically inhibits the synthesis of glycosaminoglycan hyaluronan (HA), which is its main mechanism of action. This agent reduces the availability of HA substrates and inhibits the activity of different HA synthases. However, an effect independent of HA synthesis has also been observed. 4-MU acts as an inhibitor of tumor growth in different types of cancer. Particularly, 4-MU acts on the proliferation, migration and invasion abilities of tumor cells and inhibits the progression of cancer stem cells and the development of drug resistance. In addition, the effect of 4-MU impacts not only on tumor cells, but also on other components of the tumor microenvironment. Specifically, 4-MU can potentially act on immune, fibroblast and endothelial cells, and pro-tumor processes such as angiogenesis. Most of these effects are consistent with the altered functions of HA during tumor progression and can be interrupted by the action of 4-MU. While the potential advantage of 4-MU as an adjunct in cancer therapy could improve therapeutic efficacy and reduce toxicities of other antitumoral agents, the greatest challenge is the lack of scientific evidence to support its approval. Therefore, crucial human clinical studies have yet to be done to respond to this need. Here, we discuss and review the possible applications of 4-MU as an adjunct in conventional antineoplastic therapies, to achieve greater therapeutic success. We also describe the main proposed mechanisms of action that promote an increase in the efficacy of conventional antineoplastic strategies in different types of cancer and prospects that promote 4-MU repositioning and application in cancer therapy.

Main trends of functional bakery products market development

At present the problem of healthy nutrition is receiving more and more attention, therefore, functional foods that compensate for the deficiency of macro- and micronutrients, preserve and improve health, are becoming more in demand. Trends in the development of the market for functional bakery products have been analyzed. The official data of the Rosstat, EMISS, FSAEI SRICHI, information and analytical centers, legislative and regulatory acts of the Russian Federation have been the informational basis of the research. According to the Rosstat data, the output of bakery products in 2020 amounted to 5,4 million tons, of which the share of dietary products was 1%, and the share of functional (fortified) bakery products was only 0,5%. Analysis of the market for functional bakery products showed that their production is extremely unevenly distributed across the regions of the Russian Federation. The volume of production of functional (fortified) and dietetic bakery products in the total production in the Southern Federal District is below the all-Russian level – 0,44%, while in the Krasnodar Territory it is 0,74%. Analysis of the range of functional bakery products on the Russian market shows that the largest share in the consumer market is occupied by iodized bakery products with a high content of dietary fiber, enriched with vitamins and minerals. Based on the results of the analysis of the Russian consumer market of bakery products, a reasonable conclusion has been made that the segment of functional bakery products is extremely limited, and their range does not always correspond to the modern needs of the population. It has been shown that it is relevant to expand the range of functional bakery products, the use of which will provide the human body’s need for the necessary macro- and micronutrients for an active and healthy lifestyle.

Frutalose®, a mixture of fructans obtained from enzymatic hydrolysis of chicory inulin, and normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Sensus B.V. (Royal Cosun), submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and maintenance of normal defecation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that Frutalose®, a mixture of fructans obtained from enzymatic hydrolysis of chicory inulin, is sufficiently characterised. The claimed effect proposed by the applicant is ‘contributes to regular bowel function by increasing stool frequency’. The proposed target population is ‘the general healthy adult population’. Maintenance of normal defecation is a beneficial physiological effect provided that it does not result in diarrhoea. One human intervention study showed an effect of Frutalose® on the maintenance of normal defecation by increasing stool frequency and improving stool consistency (softer stools) when consumed daily at a dose of 15 g for 8 weeks. The results have not been replicated in other studies. There is a plausible mechanism by which Frutalose® could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Frutalose® and maintenance of normal defecation under the proposed conditions of use.

Assessment and Updating of the Fortification Model from 2006

In 2006 the, the Panel on Nutrition, Dietetic Products, Novel Food and Allergy in the Norwegian Scientific Committee for Food Safety (VKM) adapted a Danish model for assessing applications concerning food fortification into Norwegian conditions. The fortification model is presently used by the Norwegian Food Safety Authorities as a tool in the management of applications on food fortification.
 
 The model from 2006 was based on intake calculations from dietary surveys from 1997-2000. Since then, new national dietary surveys have been published. These are the comprehensive nationwide Norwegian dietary surveys among adults (Norkost 3, 2010-2011), among young children (Småbarnskost, 2007) and infants (Spedkost, 2006-2007). The Norwegian Food Safety Authority has requested VKM to implement the new data into the fortification model from 2006.
 
 In the model from 2006 it is assumed that 25% of the energy in the diet can be derived from fortified foods and drinks. Information from the Norwegian Food Safety Authority, including about a pilot study for Norkost 3 suggested that the overall intake of fortified foods and drinks was marginal. From management of applications for fortified foods, the Norwegian Food Safety Authority also experienced that there are few fortified foods on the market in Norway. The Norwegian Food Safety Authority has therefore requested VKM to evaluate whether the assumption that 25 energy percent (E%) deriving from fortified foods can be reduced to 15 E%, and if such a reduction will have health implications. In addition, the Norwegian Food Safety Authority has asked VKM to perform an evaluation of the safety factors in the model.
 
 VKM argues that the model for fortification should be based on the dietary intake of vitamins and minerals at the 95th percentile level in various age groups. This is in accordance with risk assessments performed in European Food Safety Authority (EFSA), and will assure that the dietary intake in a majority of the population will be covered, still within a reasonable secure use of dietary exposure calculations. Mean intake of vitamins and minerals from food supplements (among users only) was chosen, in an attempt to reduce the impact of those with a high intake of supplements. The intake at 95th percentile from the diet plus the mean nutrient intake from supplements is deducted from the tolerable upper intake level (UL) for each nutrient in each age group, giving the maximum amount of nutrients that can be “allocated” for food fortification. The maximum amount of a nutrient that can be “allocated” is then distributed over the energy intake at the 95th percentile level. In this manner an estimate is made showing which age group is most likely to have an excessive intake of a certain nutrient. 
 
 VKM does not have access to any other information about available fortified foods on the Norwegian market than the information given by the Norwegian Food Safety Authority. However, based on this information, VKM considers that it seems reasonable that the energy intake from fortified foods is reduced to 15 E%. In this revised fortification model the assumption from 2006 that 25 E% of the total energy intake will be derived from fortified foods, have therefore been reduced to 15 E%. This adjustment implies that the addition of e.g. vitamin D, vitamin E, thiamine, riboflavin, niacin, folic acid, vitamin B12, vitamin C and calcium per 100 kcal can be increased without risk of exceeding UL. No changes are made for e.g. vitamin A, beta-carotene, magnesium, iron, zinc or copper. A more summary is presented in Table 1 and Appendix 1.
 
 The Panel on nutrition, dietetic products, novel food and allergy considers that this model for management of fortification will reduce health risk that could be caused by unauthorised food fortification.

Assessment of Creatine in Sports Products

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has at the request of the Norwegian Food Safety Authority (Mattilsynet) conducted an assessment of creatine in sports products (e.g. supplements). The evaluation has been performed by an ad hoc group, and assessed by the VKM Panel on nutrition, dietetic products, novel food and allergy.
 
 The evaluation of safety and possible risks of creatine supplementation in this opinion is based on previous reports, 23 original papers and 14 reviews from literature searches.
 
 Marketing and sales of sport products are increasing in the Nordic countries, with creatine supplements being one of four most common categories. In addition to be used by athletes, the use of creatine supplements seems to increase among general exercisers and young people. Creatine supplements are mainly used for their supposed effects on muscles mass and high intensity and short duration sport performances. Supplementation has been shown to result in higher concentration of creatine phosphate in the muscles, which is the limited substrate.
 
 For athletes, it is recommended a loading dose of 10-20 g/day for 4-7 days and a maintenance dose of 2-5 g/day for weeks or months. Some athletes continue the maintenance dose for several years. It is well documented that creatine supplementation has positive effects on muscle mass combined with strength training and performance during maximal exercise. There are however large individual variation in the response, and there are responders and non-responders.
 
 The new scientific literature, including long term studies, is in line with the EFSA (European Food Safety Authority) opinion from 2004.
 
 VKM Panel on nutrition, dietetic products, novel food and allergy supports the EFSA conclusion that supplementation of creatine in doses below 3 g/day is unlikely to pose any risks if the purity of the creatine compound is adequate. 
 
 Scientific long-term studies with doses up to 5-10 g/day in adult athletes have shown no harmful effects, but there are no dose-response studies indicating a safe upper limit for creatine. 
 
 The potential negative effects (impaired kidney function, weight gain and gastrointestinal disturbances) which have been published in non scientific journals and anecdotal reports have not found support in controlled systematic studies on healthy subjects. It has been indicated that individuals with impaired kidney functions should refrain from creatine supplements.
 
 Creatine-monohydrate is the most studied form of creatine supplements, and only creatine monohydrate has been included in the scientific investigations on adverse effects.

Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013.

[Table: see text] Following a request from the European Commission in 2014, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance on foods for special medical purposes (FSMP) in the context of Article 3 of Regulation (EU) No 609/2013. The guidance presented in this document is to assist in the preparation and presentation of well-structured dossiers. It presents a common format for the organisation of the information and outlines the information and scientific data which could be included in the dossier, as well as the key issues which should be addressed in the dossier in order to assess the extent to which a food product notified as FSMP falls under the scope of Regulation (EU) No 609/2013, under the proposed use. It is intended that the guidance will be kept under review and will be further amended and updated as appropriate in the light of experience gained from the evaluation of dossiers for specific food products notified as FSMP, and in the light of future Community guidelines and legislation. The scope of this guidance is limited to FSMPs in the context of Article 3 of Regulation (EU) No 609/2013. Out of the scope of this guidance are: a) other categories of food falling under Regulation (EU) No 609/2013, such as infant formula and follow-on formula, processed cereal-based food and baby food, and total diet replacement for weight control; b) meal replacements for weight control; c) "gluten-free" and "lactose-free" foods. Upon request from the European Commission in 2020, this guidance has been revised to inform applicants of new provisions in the pre-submission phase and submission application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021.

Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow‐on formula manufactured from protein hydrolysates (Revision 1) 1

Endorsement date21 January 2021Implementation date27 March 2021 Following a request from the European Commission, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the nutritional safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specificdossiers, and in the light of applicable Unionguidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre‐submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.

Guidance on the preparation and presentation of applications for exemption from mandatory labelling of food allergens and/or products thereof pursuant to Article 21 (2) of Regulation (EU) No 1169/2011.

[Table: see text] Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on Scientific and technical guidance for the preparation and presentation of applications for exemption from mandatory labelling of food allergens and/or products thereof. This guidance applies to food ingredients or substances with known allergenic potential listed in Annex II of Regulation (EU) No 1169/2011 or products thereof, and aims to assist applicants in the preparation and presentation of well-structured applications for exemption from labelling. It presents a common format for the organisation of the information to be provided and outlines the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, reflecting the relative strength of evidence which may be obtained from different study types and the key issues which must be addressed in the application in order to assess the likelihood of a food allergen-derived preparation/foodstuff(s) triggering adverse reactions in sensitive individuals under the proposed conditions of use. This guidance document was adopted by the NDA Panel in 2013 and updated in 2017 to reflect the application of Regulation (EU) No 1169/2011. Upon request from the European Commission in 2020, it has been revised to inform applicants of new provisions in the pre-submission phase and submission application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021.

General scientific guidance for stakeholders on health claim applications (Revision 1).

[Table: see text] The general guidance for stakeholders on the evaluation of Article 13(1), 13(5) and 14 health claims was first published in March 2011. Since then, the Panel on Dietetic Products Nutrition and Allergies (NDA) has completed the scientific assessment of Article 13(1) claims except for claims put on hold by the European Commission, and has assessedadditional health claim applications submitted pursuant to Articles 13(5), 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need to be further clarified and addressed. This guidance document aims to explain the general scientific principles applied by the NDA Panel for the scientific assessmentof all health claims and outlines a series of steps for the compilation of applications. The general guidance document represents the views of the NDA Panel based on the experience gained to date with the scientific assessment of health claims, and it may be further updated, as appropriate, when additional issues are addressed.The document also aims to inform applicants of newprovisionsin the pre-submission phase and in the application procedure set out in the General Food Law, as amended by the Transparency Regulation. These new provisions are applicable to all applications submitted as of 27 March 2021. The version of this guidance published in 2016 remains applicable for applications submitted before 27 March 2021.

Promoting Breastfeeding and Interaction of Pediatric Associations With Providers of Nutritional Products.

Pediatric associations have been urged not to interact with and not to accept support from commercial providers of breast milk substitutes (BMSs), based on the assumption that such interaction would lead to diminished promotion and support of breastfeeding. The leadership of seven European pediatric learned societies reviewed the issue and share their position and policy conclusions here. We consider breastfeeding as the best way of infant feeding and strongly encourage its active promotion, protection, and support. We support the World Health Organization (WHO) Code of Marketing of BMSs. Infant formula and follow-on formula for older infants should not be advertised to families or the public, to avoid undermining breastfeeding. With consistently restricted marketing of BMSs, families need counseling on infant feeding choices by well-informed pediatricians. Current and trustworthy information is shared through congresses and other medical education directed and supervised by independent pediatric organizations or public bodies. Financial support from commercial organizations for congresses, educational, and scientific activities of pediatric organizations is an acceptable option if scientific, ethical, societal, and legal standards are followed; any influence of commercial organizations on the program is excluded, and transparency is ensured. Public–private research collaborations for improving and evaluating pharmaceuticals, vaccines, medical devices, dietetic products, and other products and services for children are actively encouraged, provided they are guided by the goal of enhancing child health and are performed following established high standards. We support increasing investment of public funding for research aiming at promoting child health, as well as for medical education.